This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020. The study will enroll healthy participants at low doses, followed by participants with moderate to severe autoimmune diseases with predominant B-cell involvement. Eligible participants include patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), Sjögren's disease (SjD), and rheumatoid arthritis (RA).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Liquid formulation, administered through intravenous infusion
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through Week 48
Time frame: Up to Week 48
Number of Participants With Signs Characteristic of Cytokine Release Syndrome (CRS), Immune Related Reaction (IRR), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Including Immunosuppression-Related Infection
Time frame: Up to Week 24
Number of Participants With Dose limiting AE Evaluation During Dose Escalation
Time frame: Up to Day 15
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Up to Week 24
Number of Participants With Clinically Significant Changes in Physical Examination Findings
Time frame: Up to Week 24
Change From Baseline in Serum Interleukin-6 (IL-6)
Time frame: Up to Week 20
Change From Baseline in Serum Tumour Necrosis Factor-Alpha (TNF-α)
Time frame: Up to Week 20
Change From Baseline in Serum Interferon-Gamma (IFN-γ)
Time frame: Up to Week 20
Change From Baseline in Serum High Sensitivity C-Reactive Protein (hsCRP)
Time frame: Up to Week 20
Change From Baseline in Serum Erythrocyte Sedimentation Rate (ESR)
Time frame: Up to Week 20
Change From Baseline in Serum Ferritin
Time frame: Up to Week 20
Change From Baseline in Serum Immunoglobulin G (IgG)
Time frame: Up to Week 20
Area Under the Concentration-Time Curve From Time Zero to Last Observable Concentration (AUCt) of HBM7020
Time frame: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of HBM7020
Time frame: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Maximum Observed Plasma Concentration (Cmax) of HBM7020
Time frame: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Time to Maximum Observed Plasma Concentration (tmax) of HBM7020
Time frame: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Number of Participants With Anti-Drug Antibodies (ADA) to HBM7020
Time frame: Up to Week 24
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